Acetaminophen Tablet
FDA Label NDC 70010-161

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Granules Pharmaceuticals Inc. for the product Acetaminophen (NDC 70010-161). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each Caplet)

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ Stop Use And Ask Doctor If

→ If Pregnant Or Breast-feeding

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments ?

→ Principal Display Panel

Active Ingredient (In Each Caplet)

Acetaminophen, USP 500 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:

• the common cold

• headache

• backache

• minor pain of arthritis

• toothache

• muscular aches

• premenstrual and menstrual cramps

• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe Liver damage may occur if you take

• more than 4,000 mg of acetaminophen 24 hours.

• with other drugs containing acetaminophen

• 3 or more alcoholic drinks everyday while using this product

Allergy alert: acetaminophen may cause severe skin reactions.Symptoms may include:

• skin reddening

• blisters

• rash

If a skin reaction occurs, stop use and seek medical help right away.

Do Not Use

• with any other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

• if you are allergic to acetaminophen or any other inactive ingredients in this product.

Ask A Doctor Before Use If You Have

liver disease.

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.

Stop Use And Ask Doctor If

• pain gets worse or lasts more than 10 days

• fever gets worse or lasts more than 3 days

• new symptoms occur

• redness or swelling is present

These could be signs of a serious condition.

If Pregnant Or Breast-Feeding

ask a health professional before use.

Keep Out Of Reach Of Children

Over dose warning: In case of overdose, get medical help or Contact Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed (see overdose warning)

adults and children 12 years and over	• take 2 caplets every 6 hours while symptoms last • do not take more than 6 caplets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor
children under 12 years	• ask a doctor